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2023 - 2024 LEGISLATURE
2023 ASSEMBLY BILL 849
December 22, 2023 - Introduced by Representatives VINING, C. ANDERSON, J.
ANDERSON, CLANCY, CONLEY, CONSIDINE, DRAKE, EMERSON, JOERS, MADISON,
OHNSTAD, ORTIZ-VELEZ, RATCLIFF, SHANKLAND and SINICKI, cosponsored by
Senators SPREITZER, SMITH, TAYLOR, WIRCH and AGARD. Referred to Committee
on Health, Aging and Long-Term Care.
***AUTHORS SUBJECT TO CHANGE***
AN ACT to amend 450.13 (title); and to create 450.13 (5n) of the statutes;
relating to: therapeutic interchange for drug products prescribed to
counteract anaphylaxis.
Analysis by the Legislative Reference Bureau
This bill allows a pharmacist to substitute a drug product prescribed to
counteract anaphylaxis with another drug product that would, in the opinion of the
pharmacist, have a substantially equivalent therapeutic effect even though the
substitute drug product is not a drug product equivalent if certain conditions are met.
The bill also provides that a pharmacist who dispenses a drug product for a patient
in a hospital may, for a drug product prescribed to counteract anaphylaxis, under the
same conditions applicable for drug product equivalents under current law,
substitute a drug product with another drug product that would, in the opinion of the
pharmacist, have a substantially equivalent therapeutic effect even though the
substitute drug product is not a drug product equivalent. Current law defines a
“drug product equivalent” as a drug product that is designated the therapeutic
equivalent of another drug product by the federal Food and Drug Administration as
set forth in the latest edition of the supplement to the federal Food and Drug
Administration's Approved Drug Products with Therapeutic Equivalence
Evaluations, commonly known as the Orange Book. As with substitution of drug
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product equivalents under current law, the therapeutic substitutions allowed under
the bill do not apply to biological products.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
SECTION 1. 450.13 (title) of the statutes is amended to read:
450.13 (title) Using drug product equivalent in dispensing
prescriptions; therapeutic exchange for drug products prescribed to
counteract anaphylaxis.
SECTION 2. 450.13 (5n) of the statutes is created to read:
450.13 (5n) THERAPEUTIC INTERCHANGE FOR DRUGS COUNTERACTING ANAPHYLAXIS.
(a) Notwithstanding subs. (1s) to (4), for a drug product prescribed to counteract
anaphylaxis, a pharmacist may substitute a drug product with another drug product
that would, in the opinion of the pharmacist, have a substantially equivalent
therapeutic effect even though the substitute drug product is not a drug product
equivalent, provided all of the following conditions are met:
1. A prescribing practitioner has not indicated, by writing on the face of the
prescription order or, with respect to a prescription order transmitted electronically,
by designating in electronic format that a substitution of the drug product prescribed
may not be made under this subsection. If such indication is made, the pharmacist
shall dispense the prescription with the specific drug product prescribed.
2. The drug product substitution is intended to ensure formulary compliance
with the consumer's health insurance plan or, in the case of a consumer without
insurance, to lower the cost to the patient while maintaining safety.
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3. The consumer opts in to the drug product substitution, and the pharmacist
clearly informs the consumer of the differences in the drug products and specifies
that the consumer may refuse the substitution.
(b) If a pharmacist substitutes a drug product prescribed to counteract
anaphylaxis under this subsection, the pharmacist must ensure that the prescriber's
directions and quantity are modified to allow for equivalent dispensing to what was
originally prescribed.
(c) Within 5 business days after the dispensing of a drug product substitute
under this subsection, the dispensing pharmacist or the pharmacist's designee shall
do one of the following:
1. Make an entry of the specific drug product provided to the patient, including
the name of the product and the manufacturer. Entry into an electronic records
system as described in this paragraph is presumed to provide notice to the
prescribing practitioner. The communication shall be conveyed by making an entry
that is electronically accessible to the prescribing practitioner through one of the
following:
a. An interoperable electronic medical records system.
b. An electronic prescribing technology.
c. A pharmacist benefit management system.
d. A pharmacy record.
2. If a pharmacist is unable to make an entry as provided in subd. 1.,
communicate the drug product substitute dispensed to the prescribing practitioner
using facsimile, telephone, electronic transmission, or another prevailing means,
except that communication under this paragraph is not required if a refill of the drug
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product is not changed from the product dispensed on the prior filling of the
prescription.
(d) Notwithstanding pars. (a) to (c), a pharmacist who dispenses a drug product
prescribed for a patient in a hospital may, for a drug product prescribed to counteract
anaphylaxis, substitute a drug product with another drug product that would, in the
opinion of the pharmacist, have a substantially equivalent therapeutic effect even
though the substitute drug product is not a drug product equivalent, if the
pharmacist dispenses the drug product substitute in accordance with written
guidelines or procedures previously established by a pharmacy and therapeutics
committee of the hospital and approved by the hospital's medical staff and use of the
drug product substitute has been approved for a patient during the period of the
patient's stay within the hospital by any of the following:
1. The patient's individual physician.
2. The patient's advanced practice nurse prescriber, if the advanced practice
nurse prescriber has entered into a written agreement to collaborate with a
physician.
3. The patient's physician assistant.
(END)
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